A key driver of the medical disposables market is the desire to minimize the risk of healthcare-associated infections (HAIs). Healthcare providers are turning to disposable products as a safer alternative than reusable devices, which even if decontaminated properly, can still lead to infection. According to Grand View Research, “the emergence of this sector is attributed to the increased focus toward the use of single-use disposable products to prevent cross-contamination and infection in healthcare settings.” In addition to the growing awareness of the benefits of infection control, another key factor driving the market expansion is the growing need for healthcare assistance for an aging population.
Echoing the findings in the report, Al Carolonza notes that with antimicrobial resistance and the rise in super-bugs, it is perhaps not surprising that disposable surgical instruments are gaining favor. “Since they are sterilized and individually packaged, they inherently reduce risk of infection. This is becoming a crucial consideration as healthcare moves toward an outcomes-based model,” says Carolonza, who is principal and director of market research and strategy for MICRO, a full-service contract manufacturer based in Somerset, NJ.
“While disposable devices are often perceived as creating more waste and are seen as less beneficial to the environment, reusable devices have their own environmental concerns as the energy, water, detergent, and electricity used to decontaminate combined with repackaging and transportation can ultimately be more impactful on the environment,” he says.
Overall, disposable devices are proving that they can help to lower costs for specific procedures while also reducing patient risks related to cleaning and sterilization. “We believe this is the reason that so many OEMs have robust development pipelines aimed at the disposable market — which is in turn creating opportunities for creative, responsive contract manufacturing organizations to provide solutions to their needs,” says Carolonza.
The research report also notes that the increasing application of various drug-delivery products for sustained-release drug therapies is contributing to the increased use of disposables. “There are a lot of reports on the growth of prefilled syringes and such, says Ravi Narayanan, global product manager — connectors, at Nordson MEDICAL, a disposables manufacturer in Loveland, CO. He says that the growth of compounding pharmacies and their use of disposables is also contributing to the overall increase of this market.
“One of the factors that is gaining momentum is the awareness and adoption of the ISO 80369 connectors in the disposables tubing sets, says Narayanan. “These are primarily the enteral, blood pressure, neuraxial, and intravascular and hypodermic tubing sets. The non-interconnectability of these prevalent tubing sets and related procedures is anticipated to have a direct impact to patient safety.”
The burgeoning disposables market is expected to reach USD $329.9 billion by 2024, even as many of the major players consolidate. Among those are 3M, Johnson & Johnson Services, Abbott, Becton, Dickinson & Company, Medtronic, B. Braun Melsungen AG, Bayer AG, Smith and Nephew, Medline Industries, and Cardinal Health. Narayanan says consolidation of key disposable tubing set manufacturers is a driver in this market. “The notable ones are BD's acquisitions of CareFusion and Bard and ICU Medical's acquisition of Hospira Infusion Systems,” he says.
Decreasing Risk, Reducing Errors
“As the medical field continues to evolve and hospitals are forced to manage tight budgets while maintaining low healthcare-associated infection (HAI) rates, innovative manufacturers are needed to help create surgical devices that will support keeping the bottom line down while minimizing risk,” says Carolonza. He adds that reusable surgical devices tend to come at a higher initial cost and require frequent maintenance to keep them in pristine condition. “Some have complex designs and intricate parts, which can be challenging to clean thoroughly of blood, tissue, or other biological debris, putting patients at possible risk for surgical site infections and contamination. Recent high-profile recalls have brought this issue back into the public eye.”
Preventing misconnections has played a big role as well. “The prevention of misconnections between small bore connectors used in different applications has been a driving factor for design change since the ISO 80369 standards for small-bore connectors were introduced,” says Scott Herskovitz, president and CEO of Qosina, a manufacturer of disposables in Ronkonkoma, NY, whose mission is to promote initiatives surrounding safe and optimal delivery of enteral feeding and connectivity. “Because everyone has a responsibility for patient safety, new design guidelines were developed due to several incidents resulting from inappropriate medications, liquid nutritional formula, or air being misconnected, which caused catastrophic consequences.” He adds that industry manufacturers and healthcare professionals changed the configuration of male and female enteral connectors, making them larger and not allowing connectivity with the male or female luer connectors that meet the ISO 594 standards or any other connectors for other clinical use.
In an effort to improve patient safety, Qosina, which is a member of the Global Enteral Device Supplier Association (GEDSA), added a number of enteral feeding connectors to its inventory. Its ENFit™ line meets the ISO 80369-3 standard, which has been developed by the International Organization for Standardization to reduce the risk of small-bore misconnections used in liquid and gas healthcare applications.
Qosina also provides NRFit™ products, which are compliant with ISO 80369-6. This standard addresses neuraxial applications involving the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anesthesia delivery, and other regional anesthesia procedures, or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. Currently, Qosina is working with manufacturers on the additional testing needed to bring components into ISO 80369-7 compliance, which specifies dimensions and guidelines for the design and function of connections used in intravascular applications or hypodermic connections, again intended to reduce the risk of small-bore misconnections.
“Characteristics based on their inherent design and dimensions are designed and manufactured in order to reduce the risk of misconnections. This will ultimately stop the use of universal connectors used in close proximity to a single patient,” says Herskovitz.
Medical device development has evolved in recent years to address unmet medical needs, cost efficiencies, tight deadlines, product volume, material selection, improved patient safety, and effective patient outcomes, notes MICRO's Carolonza. Reusable devices, he explains, are designed and built to last indefinitely — assuming proper maintenance and cleaning. Disposable devices, by design, have less-demanding durability requirements. “While both devices require precision parts and must function similarly in practice, the design and durability requirements of disposable devices allow for more cost-effective mass production techniques. For instance, metal stamping can produce precision parts that are less durable — but also far less costly — than the more time-consuming discipline of machining similar parts for reusable devices.”
Metal tubing, for example, is the backbone of virtually every handheld surgical device. “We have many options at MICRO that allow us to drastically reduce tubing costs on disposable instruments. Our patented Rolled Tube Technology allows us to stamp a tube out of flat stock, resulting in a finished tube with complex features that leaves the press at a speed of one per second. We produce over 1 million of these tubes per year for leading OEMs in the disposable device marketplace,” says Carolonza.
We have also found that combining automation with material from our own tube mill allows for vastly improved efficiency in operations such as flaring and flanging, piercing and slotting, and laser cutting, welding, and marking. This translates to best-in-class quality and value — a strong value proposition for our single-use device clients.”
Narayanan agrees that the advances in disposables are driving both the need for automation and the need for precision in manufacturing.
On the Horizon
A new ANSI standard is in development that will affect the development of disposable medical devices. With input from industry leaders, AAMI is developing the ANSI standard for the needle-free lueractivated valves. “These valves are ubiquitous and notably found in intravascular tubing sets,” says Narayanan, who is the co-chair of the AAMI committee. “Thus far, there has been no regulatory or industry-wide standard that defines the characteristics and requirements for this standard. We anticipate that this standard will publish in 2019.”
The market for disposables is on the rise as hospitals and other healthcare facilities face the need to minimize the risk of HAIs and to meet the increasingly stringent infection control requirements. Disposable products can offer a safer alternative than reusable devices as they prevent cross-contamination. Disposable medical products offer other advantages as well, including reducing sterilization and disinfection costs.